Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,434
Critical: 7
Severe: 107
Most recent: 2026-09-09

Of the 1,434 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 107 (7%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1101–1125 of 1434

SevereFDA (Devices)·Z-2736-2018·2018-08-15
FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints
Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.
Product
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2432-2018·2018-07-25
Medtronic Vectris MRI Lead Kit Recalled for Needle Defect
Medtronic is voluntarily recalling Vectris Sure Scan MRI Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.
Product
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional co
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2431-2018·2018-07-25
Medtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect
Medtronic is voluntarily recalling Vectris Trial Screening Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.
Product
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurost
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2256-2018·2018-06-27
Pentax C2 CryoBalloon Focal Catheter Recalled for Connector Alignment Defect
Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.
Product
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0868-2018·2018-06-20
MBi Nutraceuticals Recalls Homeopathic Nausea Drops Due to Manufacturing Controls
MBi Nutraceuticals is voluntarily recalling Nausea Drops and other homeopathic products due to a lack of adequate manufacturing controls.
Product
Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0872-2018·2018-06-20
MBi Recalls Homeopathic Products Due to Manufacturing Control Deficiencies
MBi Distributing Inc. is voluntarily recalling several homeopathic products, including Argentum Elixir, due to a lack of adequate manufacturing controls.
Product
Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0870-2018·2018-06-20
MBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products
MBi Nutraceuticals is voluntarily recalling Stomach Calm and other homeopathic products due to inadequate manufacturing controls.
Product
Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2111-2018·2018-06-13
CareFusion Recalls Alaris Extension Sets Due to Incorrect Tubing
CareFusion 303, Inc. is recalling Alaris Extension Sets with microbore tubing because manufacturing errors resulted in incorrect priming volumes.
Product
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV a
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-1912-2018·2018-05-30
Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices
Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.
Product
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at o
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1894-2018·2018-05-30
Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects
Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.
Product
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemi
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1703-2018·2018-05-16
DePuy Recalls Two Knee Implants Due to Thread Burrs
DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.
Product
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1539-2018·2018-05-09
Beaver-Visitec Recalls Osher Thermodot Markers Due to Incorrect Tip
Beaver-Visitec is recalling 110 Osher Thermodot Markers because they were manufactured with a needle tip instead of the proper flat tip.
Product
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1527-2018·2018-05-02
Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect
Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.
Product
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1528-2018·2018-05-02
EEA Hemorrhoid Stapler Recalled for Potential Welding Defect
FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.
Product
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1522-2018·2018-05-02
Zimmer Biomet Recalls Orthopedic Salvage System Locking Collars
Zimmer Biomet is recalling Orthopedic Salvage System locking collars due to a potential dry blast irregularity on the screws.
Product
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1381-2018·2018-04-25
Zimmer Biomet Recalls Segmental System Proximal Femoral Components
Zimmer Biomet is recalling specific proximal femoral components due to potential machining debris that may not have been adequately removed during cleaning.
Product
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0630-2018·2018-04-25
WipeEssentials Wet Wipes Recalled for Poor Quality Water
Diamond Wipes International is recalling WipeEssentials Wet Wipes because they were manufactured with poor quality water.
Product
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1344-2018·2018-04-18
ICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar
ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.
Product
7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1363-2018·2018-04-18
Orthofix Recalls Connector System Set Screws Due to Size Discrepancies
Orthofix is voluntarily recalling specific lots of Connector System set screws because size discrepancies may prevent proper driver fit or cause stripping.
Product
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1347-2018·2018-04-18
ICU Medical Recalls Infusion Sets with Incorrect Spin Collars
ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.
Product
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1342-2018·2018-04-18
ICU Medical Recalls Smallbore Extension Sets with Incorrect Spin Collars
ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.
Product
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, steril
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1317-2018·2018-04-18
Smith & Nephew Recalls D-RAD Self-Tapping Locking Screws
Smith & Nephew is recalling D-RAD Self-Tapping Locking Screws because they were machined out of specification. The screws measured over tolerance within the head thread form.
Product
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1345-2018·2018-04-18
ICU Medical Recalls 7-inch Smallbore Infusion Sets with Incorrect Spin Collar
ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.
Product
7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device wh
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1343-2018·2018-04-18
ICU Medical Recalls Infusion Sets with Incorrect Spin Collars
ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.
Product
6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1346-2018·2018-04-18
ICU Medical Recalls Smallbore Extension Sets Due to Incorrect Spin Collar
ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.
Product
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic devic
Category
Medical Device
Distribution
Distributed nationwide